Aqueous sorbitol enema solution and method of using same



United States Patent D 2,992,970 AQUEOUS SORBITOL ENEMA SOLUTION AND METHOD OF USING SAME Victor H. Baptist, Burbank, and Arthur Cherkin, Los

'Angeles, Calif., assignors to Don Baxter, Inc., Glendale, Calif., a corporation of Nevada No Drawing. Filed Sept. 23, 1957, Ser. No. 685,430

10 Claims. (Cl. 167--50) This invention relates to an aqueous enema solution, and particularly to a solution which is safe for use in cardiac and diabetic patients.

Enemas are used to evacuate the bowel of patients or to prepare patients for sigmoidoscopic examination. In the past, a large volume of soap solution has usually been used. The large volume causes discomfort to the patient and the soap often irritates the mucous membrane. More recently, a relatively small volume of hypertonic sodium phosphate solution has been used. Such concentrated salt solutions may burn or sting if fissures, open hemorrhoids, or other anal pathologies exist. Other constituents, which may increase the effectiveness of the enema solutions, have only limited solubility in the concentrated salt solutions. Moreover, a dangerous amount of sodium may be absorbed by patients, who because of heart conditions or renal impairment are on a low-sodium diet.

The object of this invention is to provide an inexpensive, effective, evacuant enema solution having a minimum of contraindications.

Another object of the invention is to provide an effective, sodium-free enema solution.

Another object of the invention is to provide an enema solution which will not burn or irritate the rectal mucosa, or openings therein.

We have found that a 25% (weight/volume) sorbitol solution is efiective as an evacuant enema. Concentrations of sorbitol as high as 40% are effective. Concentrations of sorbitol as low as 15% may be used. The solutions of 35 to 40% tend to be sticky, however, and this causes diificulty during sigmoidoscopic examination. The preferred range is therefore l5-35% by weight of sorbitol. One hundred twenty cc. of solution is usually used, although the volume may vary from 100 to 140 cc.

The enema solution of this invention does not cause irritation or burning of fissures or other open places in the rectal mucosa. Moreover, it may be used by patients with cardiac or renal impairment and in diabetic patients. Adequate quantities of a fecal softening agent, such as a salt of dioctyl sulfosuccinic acid, and of a preservative, such as a mixture of methyl and propyl parabens or potassium benzoate, can be dissolved in the enema solution.

The preferred softening agent is potassium dioctyl sulfosuccinate. Concentrations of 0.03 to 0.5 are effective, with 0.1% being preferred. The higher concentrations of potassium dioctyl sulfosuccinate are used for more dilute sorbitol solutions and the lower concentrations for more concentrated solutions.

Under some conditions this enema solution forms a stable foam. This foam interferes with preparation and filling of the solution. Also, when the enema is administered to a patient, the foam interferes with rectal examination, or may cause the patient to have gas pains. It may therefore be desirable to add a defoamer, preferably of the silicone type. Methylpolysiloxane has been found particularly effective in concentrations of 0.2 to ppm.

The enema solution of this invention may be sterilized by heat. Preferably, however, it contains a preservative, such as 0.03 to 0.3% of a salt of benzoic acid. Potassium benzoate is preferred but other benzoates may also be used. Parahydroxy benzoates (parabens) may also be used. A combination of 0.15% methyl para- 2,992,970 Patented July 18, 1961 Example 1 Sorbitol kilograms 25 Potassium dioctyl sulfosuccinate grams Potassium benzoate do 100 istilled Water, quantity to makelOO liters.

Stoichiometn'c quantities of benzoic acid and potassium hydroxide are dissolved in 40 liters of water giving a pH of approximately 5.3. The desired amount of sorbitol is then added as the 70% solution. The potassium dioctyl sulfosuccinate is dissolved in water to form an 0.5% solution and added to the mixture. Distilled water is added to the final desired volume of 100 liters.

Example 2 Sorbitol kilograms 40 Potassium dioctyl sulfosuccinate grams 50 Methyl parahydroxybenzoate do Propyl parahydroxybenzoate do 30 Distilled water, quantity to make 100 liters.

Approximately 50 liters of water are placed in a tank, heated, and the methyl and propyl parahydroxybenzoates dissolved. The sorbitol is then added as the 70% solution. The potassium dioctyl sulfosuccinate is dissolved in water to form an 0.5 solution, and added to the mixture. The pH is adjusted to 5.3 with benzoic acid.

Example 3 Sorbitol kilograms 15 Sodium dioctyl sulfosuccinate "grams" 500 Sodium benzoate do 100 30% solution of methylpolysiloxane do 34 Distilled water, quantity to make 100 liters.

Sorbitol, dioctyl sulfosuccinate and sodium benzoate are dissolved in 40 liters of water and the pH adjusted to 5.3. The methylpolysiloxane solution is added and distilled water added to a final volume of 100 liters.

Example 4 Sorbitol kilograms 20 Potassium dioctyl sulfosuccinate grams 150 Potassium benzoate do 500 Methylpolysiloxane do 1 Distilled Water, quantity to make 100 liters.

The solution of sorbitol, dioctyl sulfosuccinate and potassium benzoate is made up as in Example 1. The methylpolysiloxane is added as an emulsion in a nontoxic emulsifying agent. The mixture is diluted to 100 liters with distilled water.

We claim:

1. An aqueous evacuant enema solution containing 15 to 35% by weight of sorbitol and a nontoxic salt of dioctyl sulfosuccinic acid in distilled water.

2. A sodium-free, aqueous evacuant enema solution comprising: 15 to 35 sorbitol; 0.03 to 0.5 potassium dioctyl sulfosuccinate; .2. to 10 ppm. methylpolysiloxane; and 0.03 to 0.3% potassium benzoate.

3. An aqueous evacuant enema solution comprising:

sorbitol; potassium dioetyl sulfosuccinate; a methylpolysiloxane; and a preservative.

4. A sodium-free, aqueous evacuant enema solution comprising: about 25 sorbitol; 0.1% potassium dioctyl sulfosuccinate; 0.1% potassium benzoate; 10 ppm. methylpolysiloxane; and having a pH of substantially 5.3.'

5. An aqueous evacuant enema solution comprising: about 25% sorbitol; 0.1% of a nontoxic salt of dioctyl sulfosuccinic acid; and having a pH of substantially 5. 3.

6. An aqueous evacuant enema solution comprising: 15 to 35% sorbitol; 0.03 to 0.5% potassium dioctyl sulfosuccinate; 0.2 to 10 p.p.m. of a methylpolysiloxane defoamer; 0.05 to 0.25% methyl parahydroxybenzoate and 0.01 to 0.05% propyl parahydroxybenzoate.

7. A sodium-free, aqueous evacuant enema solution comprising: about 25% sorbitol; 0.1% potassium dioctyl sulfosuccinate; 0.15% methyl parahydroxybenzoate; 0.03% propyl parahydroxybenzoate; 10 ppm. methylpolysiloxane; and having a pH of substantially. 5.3.

8. A ready-to-use, aqueous evacuant enema solution containing 15 to 35% by weight of sorbitol in distilled water and a nontoxic salt of dioctyl sulfosuccinic acid, said salt of sulfosuccinic acid being present in a concen- 10. The process of evacuating a human patient which comprises introducing into the rectum of said patient an aqueous solution containing from 15 to 35 sorbitol.

References Cited in the file of this patent UNITED STATES PATENTS I Hardie Oct. 25,1955

OTHER REFERENCES Chem. Abst., vol. 43, page 6815b, 1949.

Wilson: J.A.M.A., vol. 158, No. 4, pages 261-263, May 28, 1955.

Modern Drug Encyclopedia, 6th Ed., pages 436 and 437, 1955.

U.S. Dispensatoiy, 25th Ed., pages 1764, 1302 and 

1. AN AQUEOUS EVACUANT ENEMA SOLUTION CONTAINING 15 TO 35% BY WEIGHT OF SORBITOL AND A NONTOXIC SALT OF DIOCTYL SULFOSUCCINIC ACID IN DISTILLED WATER. 